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Workshop on Biorelevant in-vitro Performance Testing of Orally Administered Dosage Forms Jointly organised by FIP and DIA

Sep 24 2014 1:00PM - Sep 25 2014 5:00PM | NH Musica van Leijenberghlaan 221 1082 GG Amsterdam Netherlands

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Overview 

Biorelevant in-vitro performance testing of orally administered dosage forms has become an important tool for the assessment of drug product in vivo behaviour. Biorelevant dissolution/release testing is useful for the evaluation of formulation and food effects on plasma levels and intraluminal dosage form performance after administration of oral drug products. It has also been utilised to decrease the number of in-vivo studies required during the drug development process and to mitigate the risk related to in vivo bioequivalence studies.

This workshop will discuss data on the luminal environment, its simulation, biorelevant in vitro performance testing methodologies that can be applied during product development, as well as relevant in-silico modelling methodologies. Case studies from industry will describe the application of biorelevant testing methodologies for formulation design, selection and development vs. currently applied procedures in quality control testing. In addition, presentations from the FDA and National Competent Authorities will cover the use of biorelevant testing in the evaluation of a drug’s performance.

Featured Topics 

Gastrointestinal Physiology and in vitro Simulation

  • Luminal Composition and in-vitro Simulation
  • Luminal Hydrodynamics and in-vitro Simulation
  • Biorelevant in-vitro Performance Tests: Definitions and current issues

Biopharmaceutics Tools: A European academic-industry consortium

  • Biorelevant in vitro Performance Tests
  • Evaluation of Supersaturating Drug Delivery Systems
  • Challenges in Simulating the Changing GI Environment for the Evaluation of Dosage FormPerformance
  • Evaluation of Lipid Dosage Forms

PBPK Modelling of Oral Drug Absorption

  • Coupling Biorelevant Performance Testing with PBPK Modelling
  • PBPK Modelling of Oral Drug Absorption Using Simcyp

Looking at the Regulators

  • Biorelevance versus Quality Control: Separate or bridge?
  • Biorelevant Dissolution Tests: When, Why, How

There will be a discussion and a chance for attendees to ask questions at the end of each session.

Who Should Attend 

Scientists from industry, academia and regulatory agencies, including graduate students with a primary interest in development of orally administered drug products. The programme is designed to benefit scientists, who are already working in oral dosage formulation development

Hotel & Travel 

We have blocked a limited number of rooms at:
Hotel NH Musica
Van Leijenberghlaan 221
1082 GG Amsterdam
The Netherlands

Tel.: +31 20 541 41 41
Email: nhmusica@nh-hotels.com

To make a booking, go to:
http://www.nh-hotels.com/events/en/event-detail/20681/_.html

At the rate of EUR 140.00 per room/night inclusive of VAT and breakfast, exclusive of city tax.

Important: The room rate is available until 13 August 2014 or until the group block is sold-out, whichever comes first.

Contact Information 

Registration Queries
DIA EMEA Contact Center
Phone: +41 61 225 51 51
Fax: +41 61 225 51 52
Monday - Friday 8:00 - 17:00 CET
diaeurope@diaeurope.org

Agenda and Event Logistics
Mara Canova, Event Planner
Phone: +41 61 225 51 40
Fax: +41 61 225 51 52
mara.canova@diaeurope.org

 

 

Program Committee 

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Agenda  

Day 1 Wednesday, Sep 24, 2014

  • 1:00PM - 1:45PM

    INTRODUCTION AND WELCOME


    Session Chair(s):

    • Horst-Dieter Friedel
      Head of External Affairs
      Bayer Pharma AG, Germany
    • Vinod P Shah, PhD
      Pharmaceutical Consultant
      Pharmaceutical Consultant, United States
  • 1:45PM - 3:15PM

    Session 1: GASTROINTESTINAL PHYSIOLOGY AND IN VITRO SIMULATION


    Session Chair(s):

    • Horst-Dieter Friedel
      Head of External Affairs
      Bayer Pharma AG, Germany
    • Cynthia K Brown
      Director Analytical Sciences Research and Development
      Eli Lilly&Co, United States

    Speaker(s):

    • Luminal Composition and in vitro Simulation
      Jennifer Dressman
      Professor of Pharmaceutical Technology
      Johann Wolfgang Goethe University Frankfurt am Main, Germany
    • Luminal Hydrodynamics and in vitro Simulation
      Grzegorz Garbacz
      CEO
      Physiolution GmbH, Germany
  • 3:15PM - 3:45PM

    COFFEE BREAK
  • 3:45PM - 5:00PM

    Session 1 continued: GASTROINTESTINAL PHYSIOLOGY AND IN VITRO SIMULATION

    Speaker(s):

    • Oral Biopharmaceutics Tools: A European Academic-Industy Consortium
      James M Butler
      Senior Investigator
      GlaxoSmithKline, United Kingdom
    • Biorelevant in vitro Performance Tests: Definitions and current issues
      Christos Reppas
      Professor of Pharmaceutics
      National and Kapodistrian University of Athens, Greece
  • 5:00PM - 6:00PM

    NETWORKING RECEPTION

Day 2 Thursday, Sep 25, 2014

  • 8:30AM - 10:45AM

    Biorelevant In Vitro Tests


    Session Chair(s):

    • Mary P Stickelmeyer
      Research Fellow
      Eli Lilly&Co, United States

    Biorelevant In Vitro Tests

    Speaker(s):

    • Evaluation of Supersaturating Drug Delivery Systems
      Joachim Brouwers
      Catholic University of Leuven, Belgium
    • Challenges in Simulating the Changing GI Environment for the Evaluation of Dosage Form Performance
      David Sperry
      Eli Lilly&Co, United States
    • Evaluation of Lipid Dosage Forms
      Caitriona O’Driscoll
      Professor of Pharmaceutics
      University College Cork, Ireland
    • Predictive Release Testing of Oral ER Dosage Forms
      Erik Soderlind
      Associate Principal Scientist
      AstraZeneca, Sweden
  • 10:45AM - 11:15AM

    COFFEE BREAK
  • 11:15AM - 1:00PM

    Session 3: PBPK MODELLING OF ORAL DRUG ABSORPTION


    Session Chair(s):

    • Vinod P Shah, PhD
      Pharmaceutical Consultant
      Pharmaceutical Consultant, United States
    • Amy Barker
      PhD, Global Quality Laboratories
      Eli Lilly&Co, United States

    Speaker(s):

    • PBPK Modeling of Oral Drug Absorption Using SimSyp
      David Turner
      Principal Scientist
      Simcyp Limited, United Kingdom
  • 12:30PM - 1:30PM

    LUNCH
  • 1:30PM - 4:30PM

    Session 4: LOOKING AT THE REGULATORS

    Speaker(s):

    • Biorelevance versus Quality Control: Separate or bridge?
      Johannes Kraemer
      Managing Director
      LQS Laboratory Quality Services, Germany
    • Biorelevant Dissolution Tests: When, Why, How?
      Representative Invited
      Scientific Administrator, Quality of Medicines, Human Medicines Evaluation Div
      European Medicine Agency
    • Michael J. Morris
      Pharmaceutical Director
      Irish Medicines Board, Ireland
  • 3:00PM - 3:30PM

    COFFEE BREAK
  • 3:30PM - 5:00PM

    Session 4 continued: LOOKING AT THE REGULATORS
  • 4:30PM - 5:00PM

    CONCLUSIONS AND FUTURE DEVELOPMENTS
  • 5:00PM - 5:00PM

    END OF WORKSHOP

Registration Fees 

Member

Member Academia
€625.00
Member Government
€625.00
Member Standard
€1100.00
Member Standard (As of 08/14/2014)
€1250.00

Non-Member

NonMember Academia
€755.00
NonMember Government
€755.00
NonMember Standard
€1400.00
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